Intraoral phototherapy devices

ABSTRACT

Intraoral phototherapy devices receive light from an associated light source and propagate the light into an oral cavity of a patient. The device comprises a light guide that receives light from an external light source. The light guide comprises a main body portion made of an optically transparent soft flexible biocompatible polymeric material sized and shaped to conform to contours of the oral cavity when inserted therein to direct the light to targeted regions of the oral cavity. The main body portion comprises a pair of spaced apart side wings sized and shaped to be received between a patient&#39;s teeth and cheeks on opposite sides of the oral cavity and a center flap intermediate the side wings for transmitting and directing the light to targeted regions of the oral cavity. A controller delivers light to the light guide in a controlled manner.

RELATED APPLICATIONS

This application claims the priority of U.S. application Ser. No.15/758,586 filed Mar. 8, 2018, which claims the benefit of InternationalApplication No. PCT/US2016/051259 filed Sep. 12, 2016, which claims thebenefit of U.S. 62/216,825 filed Sep. 10, 2015. All of which are hereinincorporated by reference in their entirety.

TECHNICAL FIELD

This invention relates generally to intraoral phototherapy devices forreceiving light from an associated light source and propagating thelight into the oral cavity of a patient by total internal reflection andemission for phototherapy treatment of targeted regions of the oralcavity.

BACKGROUND

Currently there are two known methods for administering phototherapy forthe treatment of various phototherapy treatment conditions of the mouthincluding, but not limited to Oral Mucositis (OM), low level lasertherapy and light emitting diode (LED) arrays. Oral Mucositis is one ofthe most common and highly significant toxicities of cancer therapy.

Barriers to the acceptance of low level laser therapy include the costof laser equipment and the labor intensiveness. Additionally, there areproblems with interoperator variability and the need for specializedtraining. Also patients receiving this form of treatment are required tohold their mouths open for long periods of time which is uncomfortableand becomes extremely painful as the Mucositis progresses.

LED arrays utilize a plurality of LEDs to irradiate larger areas oftissue externally. The light from these arrays penetrates the skin tostimulate the mucosal membrane. LED arrays have the advantage ofirradiating a large surface area, are simpler to implement than spotlaser systems, and are more comfortable to the patient. The maindisadvantages of using LED arrays for administering phototherapytreatment is that they lack dose control because they musttransilluminate cheek tissue and have difficulty reaching all regions ofthe oral cavity, including the tonsillar and palatal regions which arehighly susceptible to OM. Also variability in tissue thickness betweendifferent buccal regions and different patients makes it impossible toaccurately monitor and control the dose of light administered to themucosa.

SUMMARY

The present invention relates to intraoral phototherapy devices that canachieve greater accuracy of phototherapy dose control compared to theuse of LED arrays and spot laser therapy by directly delivering light totargeted regions of the oral cavity.

In an embodiment, the intraoral phototherapy device comprises a lightguide that receives light from an external light source, the light guidecomprising a main body portion made of an optically transparent softflexible biocompatible polymeric material sized and shaped to conform tocontours of the oral cavity to direct the light to targeted regions ofthe oral cavity.

In an embodiment, the main body portion comprises a pair of laterallyspaced side wings sized and shaped to be received between a patient'steeth and cheeks on opposite sides of the oral cavity for transmittingand directing the light to targeted regions of the oral cavity.

In an embodiment, the side wings support one or more solid side lightchannels integrally molded with the side wings, the side light channelsbeing generally cylindrical in shape and selectively tapered along theirlength for controlled light emission therefrom.

In an embodiment, the side light channels utilize splitting to moreevenly distribute the light to targeted regions of the oral cavity.

In an embodiment, the main body portion further comprises a center flapthat can go on top of the patient's tongue for tonsillar projection andhard and soft palate phototherapy treatment or under the tongue.

In an embodiment, one or more light sources are optically coupled torearwardly protruding end portions of the device.

In an embodiment, the light source comprises one or more LEDs that areembedded in rearwardly protruding end portions of the side lightchannels and center flap.

In an embodiment, the light source is remotely coupled to the device viaa fiber optic cable.

In an embodiment, the remote light source comprises a plurality of LEDsor a laser.

In an embodiment, the device further comprises integral top and bottomflaps that fit between a patient's gums and lips to help stabilize thedevice against rotation in the oral cavity during phototherapytreatment.

In an embodiment, the device further comprises bite pads for securingthe side wings in the oral cavity during phototherapy treatment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of an embodiment of an intraoralphototherapy device.

FIG. 2 is a top plane view of the phototherapy device of FIG. 1.

FIG. 3 is a side view of the phototherapy device of FIG. 1.

FIG. 4 is a rear view of the phototherapy device of FIG. 1.

FIG. 5 is a front perspective view of an embodiment of an intraoralphototherapy device.

FIG. 6 is a top plane view of the phototherapy device of FIG. 5.

FIG. 7 is a schematic illustration of different LED light sourceconfigurations for various embodiments of the intraoral phototherapydevice.

FIG. 8 is a side view of an embodiment of an intraoral phototherapydevice.

FIG. 9 is a front perspective view of an embodiment of an intraoralphototherapy device.

FIG. 10 is a top plane view of the phototherapy device of FIG. 9.

FIG. 11 is a front view of the phototherapy device of FIG. 9.

FIG. 12 is a side view of the phototherapy device of FIG. 9.

FIG. 13 is a rear perspective view of the intraoral device of FIG. 9.

FIG. 14 is a rear view of the intraoral device of FIG. 9.

FIG. 15 is a side view of an embodiment of an intraoral phototherapydevice.

FIG. 16 is a schematic side view of an embodiment of an intraoralphototherapy device inserted into the oral cavity of a patient with themouth substantially closed.

FIG. 17 is a schematic longitudinal section through the phototherapydevice of FIG. 16 as viewed from the front with the patient's mouth wideopen.

FIGS. 18A-18C and 19A-19C show a phototherapy device includingseparating features.

FIGS. 20A-20B show a phototherapy device and a sleeve.

FIG. 21A shows a phototherapy device including a boxed region.

FIGS. 21B and 21C show a zoomed in portion of the phototherapy device of21A.

FIG. 22 shows a view of the layers of a phototheraphy device including acladding layer.

FIG. 23 shows a view of the layers of a phototherapy device including aroughed surface.

FIG. 24 shows a phototherapy device including light sources locatedwithin the phototherapy device.

FIG. 25 shows a phototheraphy device including an airgap and reflector.

FIG. 26 shows a phototheraphy device including a roughened surface.

DETAILED DESCRIPTION

Referring now more particularly to the drawings, wherein the samereference numbers are used to designate like parts, and initially toFIGS. 1-4, there is shown an embodiment of an intraoral phototherapydevice 10 comprising a light guide 12 that receives light from anexternal light source. In all of the embodiments disclosed herein, thelight guide 12 comprises a main body portion 14 made of an opticallytransparent soft flexible biocompatible polymeric material such assilicone. However, the body portion 14 may be made of other opticallyclear biocompatible soft polymeric materials as well including but notlimited to different formulations of polycarbonate, polymethylmethacrylate, polystyrene, nylon, acrylonitrile butadiene styrene,polyolefin, or other biocompatible thermoplastic elastomer formulations.

The intraoral phototherapy device may be used in a number ofapplications, several examples of which include oral mucositis, acutenecrotizing ulcerative gingivitis (ANUG), periodontal diseases, trismus,decreasing recovery time from oral surgery, light delivery fororthodontics, and photodynamic light therapy, e.g., to activate achemical mouthwash.

In the embodiment shown in FIGS. 1-4, the main body portion 14 comprisesa pair of laterally spaced side wings 16, 18 sized and shaped to bereceived between a patient's teeth and cheeks on opposite sides of theoral cavity for transmitting and directing light to targeted regions ofthe oral cavity by internal reflection and causing light to be emittedtherefrom by providing disruptions or lenses along the length of theside wings. Also the innermost ends 20, 22 of the side wings may projectlight to other targeted regions of the oral cavity.

In any of the embodiments, a reflective coating 24 may be provided onthe inwardly facing sides of the side wings to reflect light out throughthe outwardly facing sides of the side wings.

In any of the embodiments, the side wings may have a curvature that iscontoured to mandibular and maxillary buccal surfaces of the oral cavityfor emitting light thereto.

FIGS. 5 and 6 show an embodiment of an intraoral phototherapy device 30as in which the main body portion 32 includes, in addition to side wings34, 36, a center flap 38 intermediate the side wings for transmittingand directing light to other targeted regions of the oral cavity. Thecenter flap 38 can go on top of the patient's tongue for tonsillarprojection and hard and soft palate phototherapy treatment or under thetongue.

FIGS. 9-14 show an embodiment of an intraoral phototherapy device 40 inwhich the main body portion 42 includes one or more side light channels44, 46 integrally molded with the side wings 48, 50 for transmitting anddirecting light to targeted regions of the oral cavity. In anembodiment, the side light channels 44, 46 are generally solid andcylindrical in shape and are selectively tapered along their length forcontrolled light emission therefrom.

In an embodiment, each of the side light channels 44, 46 utilizessplitting to more evenly distribute the light to the targeted regions ofthe oral cavity. For example, each of the side light channels 44, 46 mayhave two or more branches 52, 54 to more evenly distribute the light tothe targeted regions of the oral cavity. Also each of the branches 52,54 may have two or more additional branches 56, 58 to further moreevenly distribute the light to the targeted regions of the oral cavity.

In an embodiment, each of the side light channels and/or branches isselectively tapered and/or has disruptions or lenses along their lengthfor controlled light emission therefrom. Also in any of the embodiments,a reflective coating 24 may be applied to the inwardly facing sides ofthe side wings to reflect light outwardly through the outwardly facingsides of the side wings/side light channels including the side lightchannel branches.

In the embodiment shown in FIGS. 9-14, the center flap 60 intermediatethe side wings 48, 50 includes one or more center light channels 62, 64that may be selectively tapered on at least one side for controlledlight emission therefrom. Also the center light channels 62, 64 may havetwo or more branches 66, 68 to more evenly distribute the light totargeted regions of the oral cavity. Further, one of the sides of thecenter light channels 62, 64 may have a flat reflective portion (seeFIG. 10) for reflecting light out the other side of the center lightchannels.

In an embodiment, at least one of the sides of the center light channels62, 64 may have disruptions or lens patterns along their length to causelight to be emitted therefrom in a controlled manner.

In all of the embodiments, one or more portions of the main body portionprotrude rearwardly beyond the side wings for optically coupling of alight source 72 thereto. In the embodiments shown in FIGS. 1-4, 5-6 and9-14, respectively, the light source 72 comprises one or more LEDs 74directly optically coupled to rearwardly protruding ends of the mainbody portion. The light source 72 may comprise multiple light sources 72and the output of the light sources 72 may vary in optical power. FIG. 7shows several different exemplary LED configurations including as few asone relatively high powered LED 74 or two or more lesser powered LEDs 74that may be mounted on a circuit board 76 inside a housing 78 attachedto the rearwardly protruding ends of the main body portion with the LEDs74 in substantially direct contact with the protruding ends or embeddedtherein as schematically shown in FIG. 10.

In other intraoral phototherapy embodiments 80 and 82 shown in FIGS. 8and 15, respectively, the light source 72 is a remote light source 73that is optically coupled to rearwardly protruding ends 84, 86 of therespective main body portions 88, 90 of the light guides 92, 94 via afiber optic cable 96.

In an embodiment, the remote light source 73 comprises one or more LEDsor a laser.

In an embodiment, a cooling system 98, 100 is provided for extractingheat away from the light source 72 (see FIGS. 2 and 6).

In the embodiment shown in FIG. 2, the cooling system 98 comprises aheat sink 102 which may include a fan 104 for moving air past the heatsink to aid in the cooling process.

In the embodiment shown in FIG. 6, the cooling system 100 comprises aliquid cooling system. For example, in FIG. 13 a liquid cooling chamber77 is shown.

In any of the embodiments, the intraoral phototherapy devices mayinclude integral arcuate flexible top and bottom flaps 106, 108 thatprotrude upwardly and downwardly from the arcuate joined rearward endsof the side wings for insertion between a patient's gums and lips tohelp stabilize the devices against rotation during phototherapytreatment.

In any of the embodiments, the intraoral phototherapy devices mayinclude bite pads 110 on the inwardly facing sides of the side wingsintermediate the height thereof adjacent the innermost ends of the sidewings as shown for as example in FIGS. 1, 2, 9, 10 and 13 for engagementby the patient's molar teeth to secure the side wings in place duringphototherapy treatment.

In any of the embodiments, the intraoral phototherapy device comprises acontroller 112 (see FIGS. 2, 6, 8, 10, 15 and 16) for delivering lightto the light guide in a controlled manner.

In any of the embodiments, the controller 112 may deliver constantlight, pulsating light and/or multiple wavelengths of light to the lightguide.

In any of the embodiments, the controller may include one or moresensors 114 (see FIGS. 9, 12, 13) that monitor one or more oftemperature, pH, salinity, moisture, humidity, conductivity andresistivity in the oral cavity during phototherapy treatment.

In any of the embodiments, the controller 112 may transmit datawirelessly from the oral cavity during phototherapy treatment.

In any of the embodiments, the controller 112 may monitor light outputfrom the light source and change input power to the light source toself-calibrate the light output from the light source.

FIGS. 16 and 17 schematically show how the intraoral phototherapy device40 of FIGS. 9-14 fits within the oral cavity 116 of a patient 118 andemits or directs light therefrom to targeted regions of the oral cavity.

To maintain uniform light delivery to the patient, an air gap may beprovided around the intraoral phototherapy device. When the intraoralphototherapy device is placed in the mouth, the air gap around theintraoral phototherapy device may be inconsistent depending on thevolume and location of saliva in the mouth and the location of contactwith tissue. When an air gap is present, the lower index of refractionof air results in light being maintained in the intraoral phototherapydevice due to total internal reflection (TIR). However, the index ofrefraction of saliva and tissue is higher than air and, for this reason,at the points of contact between the intraoral phototherapy device andsaliva or tissue may result in light being emitted from the intraoralphototherapy device at the points of contact. The variability in thecontact between the intraoral phototherapy device and saliva and tissue(both between patients and between sessions for a single patient) maymake uniform light delivery a challenge. For this reason, an air gap maybe maintained between the intraoral phototherapy device and tissue andsaliva in order to maintain TIR.

As shown in FIGS. 20A-20B, to maintain an airgap around the intraoralphototherapy device, a sleeve 210 (e.g., a disposable plastic sleeve) orcover may be utilized around the intraoral phototherapy device. Forexample, FIG. 20B shows that the sleeve 210 (represented by dottedlines) may be of a shape to receive the main body portion 14 of theintraoral phototherapy device. The sleeve 210 may be made of a verythin, flexible, optically transparent and medical grade material. Thesleeve may also act as a barrier to protect against the spread ofinfection between different users of the intraoral phototherapy device.

The interior surface of the sleeve or a surface of the intraoralphototherapy device at the point of contact between the sleeve and theintraoral phototherapy device (e.g., on the exterior of the intraoralphototherapy device) may be modified by adding separating features(e.g., roughening the surface as shown in FIG. 26) to further maintainthe airgap between the sleeve and the intraoral phototherapy device. Forexample, FIGS. 18A-18C and FIGS. 19A-19C show the addition of separatingfeatures 202 located on an exterior surface of the intraoralphototherapy device. In FIGS. 18C and 19B, the separating features 202are shown in a darker color to aid visualization of the features.

As will be understood by one of ordinary skill in the art, addingseparating features may include adding or removing material from thesleeve or the intraoral phototherapy device. For example, the separatingfeatures may include (but are not limited to) standoffs, bosses, ridges,or hexagonal protrusions. As an example, the external surface of theintraoral phototherapy device may have a surface finish between 23microns (SPI-B2) to 58 microns (SPI-C3) to maintain an airgap betweenthe intraoral phototherapy device and the sleeve.

A spacing layer may be included between the sleeve and the intraoralphototherapy device. For example, the spacing layer may comprise alow-optical-interference fabric or a porous, soft, flexible mesh. Thespacing layer may be located between the sleeve and the intraoralphototherapy device in order to trap air between the sleeve and theintraoral phototherapy device. The spacing layer may be attached to oneor more of the intraoral phototherapy device or the sleeveAlternatively, the spacing layer may not be attached to either of theintraoral phototherapy device or the sleeve.

As an alternative to or in addition to the sleeve, a hydrophobic foamcoating may be used to maintain the airgap.

As shown in FIG. 21B, a cladding layer 220 may be applied to the surfaceof the intraoral phototherapy device in order to maintain TIR of lightwithin the intraoral phototherapy device. FIG. 21A shows a zoomed inregion (square) that is expanded in FIGS. 21B and 21C. FIGS. 21B and 22show the layers of the side wing 16, cladding 220, and reflector 230.Also located outside the cladding 220 and reflector 230 are either air,tissue, or saliva. For comparison, FIG. 21C shows the layers of thesleeve 210, airgap 222, side wing 16, reflector 230, and sleeve 210.Also located outside the sleeve 210 may be air, tissue, or saliva(unlabeled). FIG. 22 also shows the layers of the sleeve 210 (labeled asdisposable cover), roughened surface (i.e., separating features 202shown in FIG. 26), intraoral phototherapy device (labeled as siliconemouthpiece), reflector 230.

The cladding layer may be configured to prevent/reduce contact betweensaliva/tissue and the intraoral phototherapy device. The cladding layermay have a refractive index that is less than or equal to 1.33 (e.g.,lower than saliva and tissue). Alternatively, the cladding layer mayhave a refractive index between 1.33 and 1.5 and may be selectivelyadded or removed in a controlled fashion. The cladding may beselectively added or removed to allow light to escape at locations wherethere is no cladding present.

The intraoral phototherapy device may include an identifier fordifferentiating between intraoral phototherapy devices. For example, theintraoral phototherapy device may include an RFID, serial number,barcode, 2D barcode, or any other suitable means for differentiatingbetween different intraoral phototherapy device. For example, theidentifier may be used to identify a particular intraoral phototherapydevice associated with a particular patient.

Turning to FIG. 24, the a intraoral phototherapy device including lightsources 240 within the main body portion 14 is shown. The light sources240 may be attached to a printed circuit board 242. The printed circuitboard 242 may be formed to control the direction of light travel withinthe intraoral phototherapy device. For example, as shown in FIG. 24, theprinted circuit board 242 is formed so that light that has been emittedfrom the light source 240 enters the center flap 38 and the side wings16, 18.

Turning to FIG. 25, the intraoral phototherapy device may include anairgap as for redirecting light within the main body portion 14. A lightsource(s) 240 may be located such that light emitted by the light source240 interacts with the airgap. The airgap 250 may reflect light towardsan inner lip of a patient when the intraoral phototherapy device 10 islocated in the patient's mouth. The airgap 250 reflects the light due tothe index of refraction difference between the material of the intraoralphototherapy device and air. As shown in FIG. 25, the airgap 250 mayalso include a reflector 252.

Although the invention has been shown and described with respect tocertain embodiments, it is obvious that equivalent alterations andmodifications will occur to others skilled in the art upon the readingand understanding of the specification. In particular, with regard tothe various functions performed by the above-described components, theterms (including any reference to a “means”) used to describe suchcomponents are intended to correspond, unless otherwise indicated, toany component which performs the specified function of a describedcomponent (e.g., that is functionally equivalent), even though notstructurally equivalent to a disclosed component which performs thefunction of the herein illustrated exemplary embodiments of theinvention. In addition, while a particular feature of the invention mayhave been disclosed with respect to a particular embodiment, suchfeature may be combined with one or more other features as may bedesired or advantageous for any given or particular application.

ASPECT LIST

Any one or more of the below listed aspects may be combined.

Aspect 1. An intraoral phototherapy device for receiving light from anassociated light source and propagating the light into an oral cavity ofa patient, the device comprising:

an external light source; and

a light guide that receives light from the external light source, thelight guide comprising a main body portion made of an opticallytransparent soft flexible biocompatible polymeric material sized andshaped to conform to contours of the oral cavity when inserted thereinto direct the light to targeted regions of the oral cavity.

Aspect 2. The device of aspect 1 further comprising a controller fordelivering the light to the light guide in a controlled manner.

Aspect 3. The device of any one of aspects 1-2 wherein the main bodyportion comprises a pair of laterally spaced side wings sized and shapedto be received between a patient's teeth and cheeks on opposite sides ofthe oral cavity for transmitting and directing the light to targetedregions of the oral cavity.

Aspect 4. The device of aspect 3 wherein the side wings support one ormore solid side light channels integrally molded with the side wings fortransmitting and directing the light to targeted regions of the oralcavity.

Aspect 5. The device of aspect 4 wherein at least some of the side lightchannels are generally cylindrical in shape and are selectively taperedalong their length for controlled light emission therefrom.

Aspect 6. The device of any one of aspects 4-5 wherein at least some ofthe side light channels have at least two branches to more evenlydistribute the light to the targeted portions of the oral cavity.

Aspect 7. The device of aspect 6 wherein at least some of the brancheshave at least two additional branches to more evenly distribute thelight to the targeted regions of the oral cavity.

Aspect 8. The device of any one of aspects 6-7 wherein at least some ofthe branches are selectively tapered for controlled light emissiontherefrom.

Aspect 9. The device of any one of aspects 4-8 wherein at least some ofthe side light channels have disruptions or lenses along their lengthfor controlled light emission.

Aspect 10. The device of any one of aspects 4-9 further comprising areflective coating on inwardly facing sides of the side wings to reflectlight outwardly through outwardly facing sides of the side lightchannels.

Aspect 11. The device of any one of aspects 4-10 wherein at least someof the side light channels utilize splitting to more evenly distributethe light to the targeted regions of the oral cavity.

Aspect 12. The device of any one of aspect 4-11 wherein rearwardlyprotruding ends of the side light channels protrude outwardly beyond theside wings, and the light source is optically coupled to the protrudingends of the side light channels.

Aspect 13. The device of aspect 12 wherein the light source comprisesone or more LEDs that are embedded in the rearwardly protruding ends ofthe side light channels.

Aspect 14. The device of any one of aspects 1-13 wherein the lightsource is remotely coupled to the device via a fiber optic cable.

Aspect 15. The device of any one of aspects 1-14 wherein the lightsource comprises one or more LEDs.

Aspect 16. The device of any one of aspects 1-14 wherein the lightsource comprises a laser.

Aspect 17. The device of any one of aspects 3-16 wherein the side wingshave a curvature that is contoured to mandibular and maxillary buccalsurfaces of the oral cavity.

Aspect 18. The device of any one of aspects 3-17 wherein the main bodyportion further comprises a center flap intermediate the side wings fortransmitting and directing the light to targeted regions of the oralcavity.

Aspect 19. The device of aspect 18 wherein the center flap includes oneor more solid center light channels.

Aspect 20. The device of aspect 19 wherein the one or more center lightchannels have two or more branches to more evenly distribute the lightto targeted regions of the oral cavity.

Aspect 21. The device of any one of aspects 18-20 wherein a forwardlyfacing end of the one or more center light channels projects light to apatient's tonsillar region.

Aspect 22. The device of any one of aspects 18-21 wherein the one ormore center light channels are selectively tapered for controlled lightemission therefrom.

Aspect 23. The device of any one of aspects 3-22 wherein one or moreportions of the main body portion protrude rearwardly beyond the sidewings.

Aspect 24. The device of aspect 23 wherein the light source is opticallycoupled to the protruding portions of the main body portion.

Aspect 25. The device of any one of aspects 23-24 wherein the lightsource comprises one or more LEDs that are embedded in the protrudingportions of the main body portion.

Aspect 26. The device of any one of aspects 23-24 wherein the lightsource is remotely coupled to the protruding portions of the main bodyportion via a fiber optic cable.

Aspect 27. The device of any one of aspects 23-26 wherein the lightsource comprises one or more LEDs.

Aspect 28. The device of any one of aspects 23-26 wherein the lightsource comprises a laser.

Aspect 29. The device of any one of aspects 3-17 further comprisingintegral arcuate flexible top and bottom flaps that protrude upwardlyand downwardly from arcuate joined rearward ends of the side wings forinsertion between a patient's gums and lips to help stabilize the deviceagainst rotation during phototherapy treatment.

Aspect 30. The device of any one of aspects 3-17 further comprising bitepads on inwardly facing sides of the side wings intermediate the sidewings' height adjacent innermost ends of the side wings for engagementby a patient's molar teeth to secure the side wings in place duringphototherapy treatment.

Aspect 31. The device of aspect 18 wherein the center flap includes oneor more solid center light channels.

Aspect 32. The device of aspect 31 wherein the center light channelshave at least two branches to more evenly distribute the light totargeted regions of the oral cavity.

Aspect 33. The device of aspect 31 wherein one or more of the centerlight channels are selectively tapered for controlled light emissiontherefrom.

Aspect 34. The device of any one of aspects 31-33 wherein one side ofthe one or more center light channels has a flat reflective portion forreflecting light out the other side of the center light channels.

Aspect 35. The device of any one of aspects 31-34 wherein at least oneof the one or more center light channels has disruptions or lenspatterns to cause light to be emitted therefrom in a controlled manner.

Aspect 36. The device of any one of aspects 1-35 wherein the lightsource is contained in a housing attached to a rearwardly protruding endof the main body portion.

Aspect 37. The device of aspect 36 further comprising a cooling systemfor extracting heat away from the light source inside the housing.

Aspect 38. The device of aspect 37 wherein the cooling system is aliquid cooling system.

Aspect 39. The device of aspect 37 wherein the cooling system is a heatsink.

Aspect 40. The device of aspect 39 further comprising a fan for movingair past the heat sink.

Aspect 41. The device of any one of aspects 2-40 wherein the controllerdelivers constant light to the light guide.

Aspect 42. The device of any one of aspects 2-40 wherein the controllerdelivers pulsing light to the light guide.

Aspect 43. The device of any one of aspects 2-40 wherein the controllerdelivers multiple wavelengths of light to the light guide.

Aspect 44. The device of any one of aspects 2-40 wherein the controllerincludes sensors that monitor temperature in the oral cavity duringphototherapy treatment.

Aspect 45. The device of any one of aspects 2-40 wherein the controllerincludes sensors that monitor one or more of pH, salinity, moisture,humidity, conductivity and resistivity in the oral cavity duringphototherapy treatment.

Aspect 46. The device of any one of aspects 2-40 wherein the controllertransmits monitored data from the oral cavity wirelessly duringphototherapy treatment.

Aspect 47. The device of any one of aspects 2-40 wherein the controllermonitors light output from the light source and changes input power tothe light source to self-calibrate the light output from the lightsource.

Aspect 48. An intraoral phototherapy device for receiving light from anassociated light source and propagating the light into an oral cavity ofa patient, the device comprising:

an external light source,

a light guide that receives light from the light source, the light guidecomprising a main body portion made of an optically transparent softflexible biocompatible polymeric material sized and shaped to conform tocontours of the oral cavity to direct the light via internal reflectionto targeted portions of the oral cavity where light is emitted from themain body portion,

the main body portion comprising a pair of laterally spaced side wingssized and shaped for receipt between a patient's teeth and cheeks onopposite sides of the oral cavity for supporting one or more solid sidelight channels integrally molded with the side wings for transmittingand directing light to targeted regions of the oral cavity.

Aspect 49. The device of aspect 48 further comprising one or more solidcenter light channels intermediate the side wings for transmitting anddirecting light to targeted regions of the oral cavity.

Aspect 50. The device of aspect 49 wherein the side light channels andcenter light channels have at least two branches that more evenlydistribute light to the targeted regions of the oral cavity.

Aspect 51. The device of any one of aspects 49-50 wherein the side lightchannels utilize splitting to more evenly distribute light to thetargeted regions of the oral cavity.

Aspect 52. The device of any one of aspects 49-51 wherein rearward endsof the side light channels and center light channels protrude rearwardlybeyond the side wings.

Aspect 53. The device of aspect 52 wherein the light source is opticallycoupled to the rearwardly protruding ends of the side light channels andcenter light channels.

Aspect 54. The device of aspect 53 wherein the light source comprises aplurality of LEDs embedded in the rearwardly protruding ends of the sidelight channels and center light channels.

Aspect 55. The device of aspect 52 wherein the light source is opticallycoupled to the rearwardly protruding ends at the side light channels andcenter light channels via a fiber optic cable.

Aspect 56. The device of any one of aspects 48-55 wherein the lightsource comprises one or more LEDs.

Aspect 57. The device of any one of aspects 48-55 wherein the lightsource comprises a laser.

Aspect 58. The device of any one of aspects 52-53 wherein the lightsource is contained in a housing attached to the rearwardly protrudingends of the side light channels and center light channels.

Aspect 59. The device of any one of aspects 48-58 further comprisingbite pads on inwardly facing sides of the side wings intermediate theside wings' height adjacent innermost ends of the side wings forengagement by a patient's molar teeth to secure the side wings in placeduring phototherapy treatment.

Aspect 60. The device of any one of aspects 48-58 further comprisingintegral arcuate flexible top and bottom flaps that protrude upwardlyand downwardly from arcuate joined rearward ends of the side wings forinsertion between a patient's gums and lips to help stabilize the deviceagainst rotation during phototherapy treatment.

Aspect 61. The device of any one of aspects 48-60 further comprising acontroller for delivering the light to the light guide in a controlledmanner.

Aspect 62. The device of aspect 61 wherein the controller deliversconstant light to the light guide.

Aspect 63. The device of aspect 61 wherein the controller deliverspulsating light to the light guide.

Aspect 64. The device of any one of aspects 61-63 wherein the controllerdelivers multiple wavelengths of light to the light guide.

Aspect 65. The device of any one of aspects 61-64 wherein the controllerincludes sensors that monitor temperature in the oral cavity duringphototherapy treatment.

Aspect 66. The device of any one of aspects 61-65 wherein the controllerincludes sensors that monitor one or more of pH, salinity, moisture,humidity, conductivity and resistivity in the oral cavity duringphototherapy treatment.

Aspect 67. The device of any one of aspects 61-66 wherein the controllertransmits monitored data from the oral cavity wirelessly duringphototherapy treatment.

Aspect 68. The device of any one of aspects 61-67 wherein the controllermonitors light output from the light source and changes input power tothe light source to self-calibrate the light output from the lightsource.

Aspect 69. A sleeve for maintaining an airgap around the intraoralphototherapy device of any of aspects 1-68, wherein the sleeve forms atleast part of a boundary of an interior volume and the sleeve is of ashape to receive the main body portion of the intraoral phototherapydevice within the interior volume.

Aspect 70. The sleeve of aspect 69 or the intraoral phototherapy deviceof any of aspects 1-68, further comprising a separating feature on aninterior surface of the sleeve and/or on an external surface of the mainbody portion of the intraoral phototherapy device, wherein theseparating feature is configured to maintain the airgap between thesleeve and the main body portion by blocking contact between the sleeveand the main body portion when the main body portion is located withinthe sleeve.

Aspect 71. The sleeve of aspect 70 or the intraoral phototherapy deviceof aspect 70, wherein the separating feature includes at least one ofstandoffs, bosses, ridges, or protrusions from the internal surface ofthe sleeve and/or the external surface of the main body portion.

Aspect 72. The sleeve of any of aspects 69-71 or the intraoralphototherapy device of any of aspects 70-71, further comprising:

a spacing layer located between the main body portion of the intraoralphototherapy device and the sleeve when the main body portion is locatedwithin the interior volume of the sleeve;

wherein the spacing layer comprises a porous material or a mesh.

Aspect 73. The intraoral phototherapy device of any of aspects 1-68 or70-72, further comprising a cladding layer applied to an externalsurface of the main body portion.

Aspect 74. The intraoral phototherapy device of aspect 73, wherein thecladding layer has an index of refraction of less than or equal to 1.33or between 1.33 and 1.5.

Aspect 75. The intraoral phototherapy device of any of aspects 73 or 74,wherein the cladding layer is applied to selective portions of theexternal surface of the main body portion.

What is claimed is:
 1. An intraoral phototherapy device for receivinglight from an associated light source and propagating the light into anoral cavity of a patient, the device comprising: an external lightsource; and a light guide that receives light from the external lightsource, the light guide comprising a main body portion made of anoptically transparent flexible biocompatible polymeric material sizedand shaped to conform to contours of the oral cavity when insertedtherein to direct the light to targeted regions of the oral cavity,wherein: the main body portion comprises a pair of laterally spaced sidewings sized and shaped to be received between a patient's teeth andcheeks on opposite sides of the oral cavity for transmitting anddirecting the light to targeted regions of the oral cavity; the sidewings support one or more not hollow side light channels integrallymolded with the side wings for transmitting and directing the light totargeted regions of the oral cavity; and each of the side light channelsare generally cylindrical in shape and are selectively tapered alongtheir length for controlled light emission therefrom; wherein the sidewings have a curvature that is contoured to mandibular and maxillarybuccal surfaces of the oral cavity.
 2. The device of claim 1 wherein atleast some of the side light channels have disruptions or lenses alongtheir length for controlled light emission.
 3. The device of claim 1further comprising a reflective coating on inwardly facing sides of theside wings to reflect light outwardly through outwardly facing sides ofthe side light channels.
 4. The device of claim 1 wherein at least someof the side light channels utilize splitting to more evenly distributethe light to the targeted regions of the oral cavity.
 5. The device ofclaim 1 wherein the main body portion further comprises a center flapintermediate the side wings for transmitting and directing the light totargeted regions of the oral cavity.
 6. The device of claim 5 whereinthe center flap includes one or more solid center light channels.
 7. Thedevice of claim 1 further comprising integral arcuate flexible top andbottom flaps that protrude upwardly and downwardly from arcuate joinedrearward ends of the side wings for insertion between a patient's gumsand lips to help stabilize the device against rotation duringphototherapy treatment.
 8. The device of claim 1 further comprising asleeve for maintaining an airgap around the light guide, wherein thesleeve forms at least part of a boundary of an interior volume and thesleeve is of a shape to receive the main body portion of the light guidewithin the interior volume.
 9. The device of claim 8, further comprisinga separating feature on an interior surface of the sleeve and/or on anexternal surface of the main body portion of the intraoral phototherapydevice, wherein the separating feature is configured to maintain theairgap between the sleeve and the main body portion by blocking contactbetween the sleeve and the main body portion when the main body portionis located within the sleeve.
 10. The device of claim 1, furthercomprising a cladding layer applied to an external surface of the mainbody portion.
 11. An intraoral phototherapy device for receiving lightfrom an associated light source and propagating the light into an oralcavity of a patient, the device comprising: an external light source;and a light guide that receives light from the external light source,the light guide comprising a main body portion made of an opticallytransparent flexible biocompatible polymeric material sized and shapedto conform to contours of the oral cavity when inserted therein todirect the light to targeted regions of the oral cavity, wherein: themain body portion comprises a pair of laterally spaced side wings sizedand shaped to be received between a patient's teeth and cheeks onopposite sides of the oral cavity for transmitting and directing thelight to targeted regions of the oral cavity; the side wings support oneor more not hollow side light channels integrally molded with the sidewings for transmitting and directing the light to targeted regions ofthe oral cavity; and each of the side light channels have at least twobranches to more evenly distribute the light to the targeted portions ofthe oral cavity; wherein the side wings have a curvature that iscontoured to mandibular and maxillary buccal surfaces of the oralcavity.
 12. The device of claim 11 wherein at least some of the branchesare selectively tapered for controlled light emission therefrom.
 13. Thedevice of claim 11 wherein at least some of the side light channels havedisruptions or lenses along their length for controlled light emission.14. The device of claim 11 further comprising a reflective coating oninwardly facing sides of the side wings to reflect light outwardlythrough outwardly facing sides of the side light channels.
 15. Thedevice of claim 11 wherein at least some of the side light channelsutilize splitting to more evenly distribute the light to the targetedregions of the oral cavity.
 16. The device of claim 11 wherein the mainbody portion further comprises a center flap intermediate the side wingsfor transmitting and directing the light to targeted regions of the oralcavity.
 17. The device of claim 16 wherein the center flap includes oneor more solid center light channels.
 18. The device of claim 11 furthercomprising integral arcuate flexible top and bottom flaps that protrudeupwardly and downwardly from arcuate joined rearward ends of the sidewings for insertion between a patient's gums and lips to help stabilizethe device against rotation during phototherapy treatment.
 19. Thedevice of claim 11, further comprising a sleeve for maintaining anairgap around the light guide, wherein the sleeve forms at least part ofa boundary of an interior volume and the sleeve is of a shape to receivethe main body portion of the light guide within the interior volume. 20.The device of claim 19, further comprising a separating feature on aninterior surface of the sleeve and/or on an external surface of the mainbody portion of the intraoral phototherapy device, wherein theseparating feature is configured to maintain the airgap between thesleeve and the main body portion by blocking contact between the sleeveand the main body portion when the main body portion is located withinthe sleeve.
 21. The device of claim 11, further comprising a claddinglayer applied to an external surface of the main body portion.